BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6382758 · Received March 6, 2017

    Report

    Report Number
    3005099803-2017-00555
    Event Type
    Injury
    Date Received
    March 6, 2017
    Report Date
    February 8, 2017
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING MEDICATION TO TREAT. ON (B)(6), 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR MODERATE ASTHMA EXACERBATION (EXACT DATE NOT REPORTED). THE PATIENT WAS TREATED WITH MEDICATION FOR THE ASTHMA EXACERBATION (MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OCCURRED. ON (B)(6) 2016 THE PATIENT WITHDREW FROM THE STUDY FOR NON-MEDICAL REASONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON 09MAR2017. THE PATIENT'S ASTHMA EXACERBATION WAS REPORTED TO BE RECOVERING. BASELINE SPIROMETRY VALUES COLLECTED ON (B)(6) 2014. (B)(6). ADDITIONAL INFORMATION RECEIVED ON 27JUN2017. THE PATIENT WAS SEEN IN THE ER AND WAS TREATED WITH SYSTEMIC CORTICOSTEROID. THE PATIENT WAS HOSPITALIZED BUT NO FURTHER INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 03NOV2017. ACCORDING TO THE COMPLAINANT, THIS ASTHMA EXACERBATION AND SUBSEQUENT HOSPITALIZATION WAS REPORTED TO BE RELATED TO THE BT PROCEDURE IN ERROR. THE COMPLAINANT CONFIRMED THAT THIS EVENT IS NOT RELATED TO THE BT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF (B)(6). THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING MEDICATION TO TREAT. ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR MODERATE ASTHMA EXACERBATION (EXACT DATE NOT REPORTED). THE PATIENT WAS TREATED WITH MEDICATION FOR THE ASTHMA EXACERBATION (MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OCCURRED. ON (B)(6) 2016 THE PATIENT WITHDREW FROM THE STUDY FOR NON-MEDICAL REASONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. **ADDITIONAL INFORMATION RECEIVED ON 09MAR2017** THE PATIENT'S ASTHMA EXACERBATION WAS REPORTED TO BE RECOVERING. BASELINE SPIROMETRY VALUES COLLECTED ON (B)(6) 2014. PRE-BRONCHODILATOR: FEV1: 1.40, FEV1 (% PREDICTED): 40, FVC: 2.67, FVC (% PREDICTED): 60. POST-BRONCHODILATOR: FEV1: 2.09, FEV1 (% PREDICTED): 60, FVC: 3.50, FVC (% PREDICTED): 79. **ADDITIONAL INFORMATION RECEIVED ON 27JUN2017** THE PATIENT WAS SEEN IN THE ER AND WAS TREATED WITH SYSTEMIC CORTICOSTEROID. THE PATIENT WAS HOSPITALIZED BUT NO FURTHER INFORMATION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING MEDICATION TO TREAT. ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR MODERATE ASTHMA EXACERBATION (EXACT DATE NOT REPORTED). THE PATIENT WAS TREATED WITH MEDICATION FOR THE ASTHMA EXACERBATION (MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OCCURRED. ON (B)(6) 2016 THE PATIENT WITHDREW FROM THE STUDY FOR NON-MEDICAL REASONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING MEDICATION TO TREAT. ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR MODERATE ASTHMA EXACERBATION (EXACT DATE NOT REPORTED). THE PATIENT WAS TREATED WITH MEDICATION FOR THE ASTHMA EXACERBATION (MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OCCURRED. ON (B)(6) 2016 THE PATIENT WITHDREW FROM THE STUDY FOR NON-MEDICAL REASONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. **ADDITIONAL INFORMATION RECEIVED ON 09MAR2017** THE PATIENT'S ASTHMA EXACERBATION WAS REPORTED TO BE RECOVERING. BASELINE SPIROMETRY VALUES: COLLECTED ON (B)(6) 2014. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162695 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 16894336

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention